Kornimate/medical-research-clean huggingface dataset:
parenteral antiplatelet agents in real-world spanish pci patients

Conditions: Ischemic Heart Disease; Acute Coronary Syndrome

Summary: this registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the pci (percutaneous coronary intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of "real-world" patients undergoing pci in spain.

the present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing pci due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, gpis or cangrelor, as per clinical practice during the procedure. this investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the pci setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing pci in spain. approximately 15 high-volume pci-capable spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients. the study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation. patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.

Eligibility criteria:
inclusion criteria: * age ≥18 years * undergoing a pci * use of a parenteral antiplatelet agent (gpis or cangrelor)during the invasive procedure (pci) exclusion criteria: * blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure. * chronic oral anticoagulation. * recent history of stroke, tia (transient ischemic attack)or intracranial bleeding (\<3 months prior to inclusion). * severe anemia (hb\<9g/dl) or platelet count \<100x106/ml at the time of the index procedure. * any active neoplasm.

Keywords: percutaneous coronary intervention antiplatelet drugs cangrelor glycoprotein iib/iiia inhibitors
aml treatment in untreated adult patients

Conditions: Leukemia, Myelocytic, Acute

Summary: the present therapy intends to be an homogeneous treatment for aml patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with daunorubicine as according to eortc-gimema aml10 study. the post-remissional treatment is based on transplant with hla compatible donor is foreseen for all patients and autologous transplant for those without hla compatible donor available.

gimema treatment for adult (15-60 yrs) aml patients included a 3-drug induction cycle with dnr (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. following consolidation, eligible pts (age \<45 or 55 yrs) with a hla compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (psc) collected during recovery from consolidation. bm and pb samples at diagnosis were centralized according to a national gimema original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. to allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (hu) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

Eligibility criteria:
inclusion criteria: * aml "de novo" with bone marrow blasts \<=30% * performance status: 0-3 * fab subtype: all except m3 * written informed consent exclusion criteria: * age \ = 61 years * pretreated aml with chemiotherapy (except idrossiurea) or radiotherapy or corticosteroids for more than 7 days. * diagnosis of acute promyelocitic leukemia (m3) * performance status = 4 * uncontrolled infection

Keywords: aml adult hydroxyurea transplant toevaluate biological characteristics at diagnosis. to identify genetic alterations with prognostic relevance. to follow up cases monitoring minimal disease during remission. to evaluate pretreatment therapy in terms of response rate and toxicity. disease free survival. overal survival.
open-label extension study of adp101

Conditions: Food Allergy

Summary: this is an open-label, safety extension study for participants who participated in the harmony study (protocol adp101-ma-01).

this study is enrolling participants by invitation only. this is a multicenter, open-label, long-term extension study of the safety and efficacy of adp101 for oral immunotherapy in food allergic children and adults who completed the harmony study (protocol adp101-ma-01).

Eligibility criteria:
key inclusion criteria: • subjects must have completed the adp101-ma-01 (the harmony study) and been compliant with study drug per protocol key exclusion criteria: * history of or current eoe, other eosinophilic gastrointestinal disease, chronic, recurrent or severe gerd, symptoms of dysphagia * hypersensitivity to epinephrine or any of the excipients in adp101 * prior or concurrent therapies as follows: * beta-blockers, ace inhibitors, arbs or calcium channel blockers * regular steroid medication use * therapeutic antibody treatment currently or within the previous 6 months * any food immunotherapy currently or within the previous 12 weeks, except adp101 * investigational agents other than adp101 * in the build up phase of non-food immunotherapy * any other condition that might preclude safe participation in the study

Keywords: adp101 allergy oral immunotherapy oit allergies food allergies multi-food allergic multi-allergen oral immunotherapy tree nut allergy milk allergy wheat allergy egg allergy fin fish allergy shrimp allergy peanut allergy sesame seed allergy soy allergy shellfish allergy fish allergy seafood allergy dairy allergy desensitization food hypersensitivity immune system disease hypersensitivity, immediate hypersensitivity
trial of monthly versus bi-weekly endoscopic variceal ligation for the prevention of esophageal variceal rebleeding

Conditions: Esophageal and Gastric Varices

Summary: many physicians suggest repeating evl every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of evl intervals of 1-2 weeks are insufficient.this randomized controlled study was conducted in order to compare the long-term results of evl when performed at two different results from monthly and bi-weekly treatments.

endoscopic variceal ligation (evl) is a safe and simple procedure now being used on a widening scale. a lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. many physicians suggest repeating evl every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of evl intervals of 1-2 weeks are insufficient.this randomized controlled study was conducted in order to compare the long-term results of evl when performed at two different results from monthly and bi-weekly treatments.

Eligibility criteria:
inclusion criteria: 1. acute or recent bleeding from esophageal varices; 2. portal hypertension caused by cirrhosis; 3. age between 18 and 80 yr. exclusion criteria: 1. history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices; 2. presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dl; 3. presence of hepatocellular carcinoma or other malignancy; 4. an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness; 5. history of gastric variceal bleeding; 6. encephalopathy of stage ii or worse; 7. failure to control initial variceal bleeding; 8. death within 48 h of admission; 9. refusal to participate in the trial.
lung ultrasonography vs fiberoptic bronchoscopy for aiding lung collapse in patient using double lumen tube

Conditions: Lung Diseases; Ultrasonography; Fiberoptic Bronchoscopy; One Lung Ventilation; Thoracic Surgery; Lung Collapse

Summary: the study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

the study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. the protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

Eligibility criteria:
inclusion criteria: * adult patients, age ≥18 years old * american society of anesthesiologists(asa) physical status classification i - iii * scheduled for elective thoracic surgery which requires one lung ventilation(olv) with left-sided double lumen tube exclusion criteria: * anticipated difficult intubation or with the tracheostomy tube * patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis * patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity \<50% of the predicted values) * the patient refuses to participate.

Keywords: lung ultrasonography lung collapse fiberoptic bronchoscopy double lumen tube compare one lung ventilation thoracic surgery thoracic anaesthesia lung ultrasound
smoking cessation, anxiety, pain relationship

Conditions: Smoking Cessation; Anxiety; Pain

Summary: smoking, anxiety and pain are clearly related conditions. we aimed to reveal the relationship between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and pain in chronic smokers. methods asa i-ii group patients without chronic disease and history of drug use were included in the study. those who did not want to participate in the study, patients with asa iii and above were excluded from the study. the patients were randomized into 2 groups: smokers (group s, n = 60) and non-smokers (group ns, n = 60). group s was asked to quit smoking 2 weeks before the operation. preoperative period and postoperative 0, 2, 4. and 6. hour spielberger state-trait anxiety inventory (stai) values, postop 0., 2., 4., 6. hour visual analogue scale (vas) values were recorded.

it has been revealed in the current study that smoking, pain and anxiety are interrelated with each other. in the preoperative period, high anxiety scores are related to surgery and anesthesia stress. high anxiety scores in the smoker group both in the preoperative period and in the postoperative period are associated with smoking cessation. while the pain scores were similar in the postoperative period, high anxiety scores strengthened the idea of smoking withdrawal and this study gained value. we believe that future studies with a large number of patients, with different parameters and multiple centers will strengthen the results.

Eligibility criteria:
inclusion criteria: * asa i,ii patients * planned rhinoplasti cases * accepted participating study exclusion criteria: * patients with chronic systemic disorders, * asa iii and above situation * emergency and bleeding cases, * patients with any cardiac and neurological disorders, * refused to participate in the study

Keywords: smoking cessation anxiety pain vas scores stai values
a feasibility study to evaluate the safety and short-term effectiveness of transcatheter pulmonary valve (tpv)

Conditions: Congenital Heart Defects; Cardiovascular Abnormalities; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis

Summary: the purpose of this study is to evaluate the safety and short-term effectiveness of implantation of transcatheter pulmonary valve (tpv) for the treatment of congenital heart disease with pulmonary valve disease.

diverse congenital heart diseases involving the pulmonary artery, such as tetralogy of fallot (tof) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(pa). because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (rv) dilation and eventual failure, patients need repetitive surgery for conduit revision. transcatheter pulmonary valve implantation (tpvi) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (rvot). tpv is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. the tpv is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional rvot requiring treatment for severe pulmonary regurgitation and/or rvot conduit obstruction. consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post tpv implantation.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 10 years of age * body weight greater than or equal to 30 kilograms * pulmonary regurgitation ≥moderate pulmonary regurgitation (pr) (≥3+) or rvot conduit obstruction with mean gradient \>35mmhg by echocardiography * pulmonary artery annulus or in situ conduit size ≥16 and ≤26mm * patient willing to provide written informed consent and comply with follow-up requirements exclusion criteria: * pre-existing mechanical heart valve in any position * obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart) * coronary artery compression * a known hypersensitivity to aspirin or heparin * immunosuppressive disease * active infectious disease (e.g. endocarditis, meningitis) * estimated survival less than 6 months * female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Keywords: pulmonary valve transcatheter pulmonary valve congenital heart disease
c-protein in fatigue and aging

Conditions: Aging; Muscle Atrophy or Weakness; Sarcopenia in Elderly; Sarcopenia

Summary: this study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

age-related muscle atrophy and contractile dysfunction have been well described at the cellular level, but the molecular mechanisms that contribute to this dysfunction are poorly understood. improved understanding of these mechanisms is critically important for the improvement of physical rehabilitation in older adults at risk for mobility impairment and physical disability. our studies will pursue pre-clinical evidence that post translational modification of specific proteins in skeletal muscle lead to an "aging phenotype" in skeletal muscle that may unlock new strategies for improving physical function in older adults with physical frailty.

Eligibility criteria:
inclusion criteria: * adults between the ages 18-35 or 65-80 years * healthy by self-report * willing to participate in all aspects of the study design including muscle biopsy, unilateral exercise, and physical activity monitoring * fluent in english (due to lack of translation services, it is not practical to conduct the study using a language other than english). exclusion criteria: * orthopaedic limitation (severe knee osteoarthritis, prior joint replacement, etc.). * volunteer has dementia or related mental issues that potentially put the subject at risk as determined by prior diagnosis. * volunteer has known untreated endocrine disease (hypo/hyper thyroidism, addison's disease or cushing's syndrome, etc.) * volunteer has untreated/poorly-controlled hypertension (stage 2, per american college of cardiology \[\>140/90 mmhg\]). * volunteer has significant heart, liver, kidney or respiratory disease. * volunteer has diabetes (insulin dependent or non-insulin dependent). * volunteer has known coagulopathies. * volunteer has taken anabolic steroids in the prior six months. * volunteer has received treatment for cancer (other than effective mohs surgery for successful removal of basal cell or squamous cell carcinomas) * unexpected weight loss \>5kg is last 12 months * volunteer is an active smoker or quit within the last year. * volunteer has known current alcohol or drug use disorder (aud; defined as binge drinking of \>4 days in the last month. binge drinking is \>5 drinks for men and \>4 drinks for women, per occasion). or, if a volunteer reports drinking in excess of "low risk" per niaaa (\>7 drinks/week for men and \>3 drinks/day for women and \>14 drinks/week and \>4 drinks/day). * volunteer has a diagnosed neuromuscular disorder. * volunteer has allergy to lidocaine.

Keywords: muscle aging elderly myosin protein sarcomere exercise function atrophy contractile strength balance mobility mybp-c fiber biopsy skeletal muscle fatigue
hysteroscopy after pretreatment with misoprostol and estradiol trial

Conditions: Cervical Ripening

Summary: the aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.


Eligibility criteria:
inclusion criteria: * all postmenopausal (\> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment exclusion criteria: * women who do not wish to participate * women who are medically unfit for hysteroscopy * women who are medically unfit for participation in any clinical trial * women who do not have a medical indication for hysteroscopy * women who have previously had, or currently have breast or gynaecological cancer * women who have a medical contraindication for locally applied oestradiol * women who are currently using hormone therapy * women who are unable to communicate in norwegian, and * women with a known allergy to misoprostol

Keywords: hysteroscopy misoprostol postmenopausal women cervical ripening dilatation sequential trial estradiol
a study to evaluate the safety and immunogenicity of inactivated varicella-zoster virus (vzv) vaccine in adults with hematologic malignancies (hm) receiving treatment with anti-cluster of differentiation (cd) 20 monoclonal antibodies (v212-013)

Conditions: Herpes Zoster

Summary: an open-label, multicenter study to evaluate the safety and immunogenicity of inactivated vzv vaccine (v212) in participants with hematologic malignancies (hm) who are currently receiving anti-cd20 monoclonal antibodies. the primary hypothesis is that vaccination with v212 vaccine will elicit significant vzv-specific immune responses at \~28 days after vaccination 4. the statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in v212 recipients is \>1.0.


Eligibility criteria:
inclusion criteria: * diagnosed with a hm and is receiving treatment with anti-cd20 monoclonal antibodies and is not likely to undergo hematopoietic cell transplant (hct). * has a predicted life expectancy of ≥ 12 months. * has prior history of varicella or antibodies to vzv due to exposure to the disease in a country where the disease is common. * all female participants of childbearing potential must have a negative serum or urine pregnancy test. exclusion criteria: * a history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin. * prior history of hz within 1 year of enrollment. * prior receipt of any varicella or zoster vaccine. * participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose. * any live virus vaccine administered or scheduled in the period from 4 weeks prior to dose 1 through 28 days postvaccination dose 4. * any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine. * participant is currently participating or has participated in a study with an investigational anti-cd20 monoclonal antibody within 3 months of signing informed consent.
feasibility study of using molecular fluorescence guided surgery in endometriosis

Conditions: Endometriosis

Summary: incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. the aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.


Eligibility criteria:
inclusion criteria: 1. females aged ≥ 18 years 2. scheduled for surgery for the treatment of endometriosis 3. who performance score of 0-2 4. written informed consent for female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: 5. a negative serum pregnancy test prior to receiving the tracer 6. willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. exclusion criteria: 1. medical or psychiatric conditions that compromise the patient's ability to give informed consent 2. pregnancy 3. history of infusion reactions to bevacizumab or other monoclonal antibody therapies 4. significant renal, cardiac, or pulmonary disease (asa iii-iv)